Effect of Probiotic and Synbiotic Administration on Nutritional Status in Hemodialysis Patients

NCT ID: NCT06891105

Last Updated: 2025-03-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-15
• Study Completion Date: 2025-11-01

Brief Summary

This study aims to investigate the impact of probiotics and synbiotics on the nutritional status of patients with end-stage kidney disease (ESRD) who are undergoing hemodialysis. ESRD patients often face challenges such as poor nutritional status, increased risk of infections, and imbalances in gut microbiota. These challenges are made worse by the frequent use of medications, dietary restrictions, and the hemodialysis process itself, which can disturb the gut's natural bacteria balance.

Probiotics are live microorganisms that provide health benefits when taken in adequate amounts, while synbiotics are a combination of probiotics and prebiotics (substances that promote the growth of beneficial bacteria). The goal of this study is to explore whether supplementing ESRD patients with probiotics or synbiotics can improve their nutritional health, including aspects like body mass index (BMI), skin fold thickness, and protein metabolism.

The study will involve 60 patients from a hemodialysis center in Mansoura, Egypt. Patients will be randomly assigned to one of three groups: one group will receive probiotics, another will receive synbiotics, and the third group will act as a control (no treatment). The study will evaluate changes in nutritional markers and other health parameters before and after six months of supplementation.

This study hopes to provide insights into new, cost-effective interventions for improving the health of patients undergoing long-term dialysis treatment by addressing the question of whether these supplements can improve the nutritional status of hemodialysis patients.

Detailed Description

This randomized controlled trial is designed to assess the effects of probiotic and synbiotic supplementation on the nutritional status of patients with end-stage kidney disease (ESRD) undergoing hemodialysis. Patients with ESRD face significant health challenges, including malnutrition, inflammation, and gut dysbiosis (an imbalance in gut bacteria), which contribute to poor health outcomes and reduced quality of life. These complications are exacerbated by the impact of the hemodialysis process, medications, and dietary restrictions commonly imposed on patients.

Probiotics are live microorganisms that provide health benefits when consumed in adequate amounts. In contrast, synbiotics combine probiotics with prebiotics, which are compounds that selectively stimulate the growth and activity of beneficial gut bacteria. The hypothesis of this study is that both probiotics and synbiotics will improve the nutritional status of hemodialysis patients by enhancing gut microbiota balance, reducing inflammation, and supporting better nutrient absorption.

Study Design: This study will be conducted at the Urology and Nephrology Center in Mansoura, Egypt. A total of 60 patients on regular hemodialysis will be randomly assigned to one of three groups:

Control group (20 patients) - No intervention. Probiotic group (20 patients) - Receives daily probiotic supplementation (Lactogemikan from Pescado Company).

Synbiotic group (20 patients) - Receives daily synbiotic supplementation (Lactogemikan plus prebiotic fiber from oats).

Each group will receive supplementation for a duration of 6 months. The primary goal is to assess the effects of these interventions on the patients' nutritional status, including the monitoring of body mass index (BMI), skin fold thickness, protein catabolic rate (PCR), and subjective global assessment (SGA) of their nutritional health. Additionally, secondary outcomes will include laboratory assessments of serum albumin, cholesterol, and fasting blood glucose.

Methodology: The patients' nutritional parameters will be measured at the start of the study and again after 6 months of supplementation. To assess dialysis adequacy, parameters like the urea reduction ratio and Kt/V (a measure of dialysis efficiency) will be recorded before and after supplementation. These assessments will provide insights into whether probiotics and synbiotics can improve both nutritional markers and dialysis outcomes.

The data will be analyzed using statistical methods including one-way ANOVA, Pearson's and Spearman's correlation, and t-tests to determine the effectiveness of each intervention compared to the control group. The study will ensure the safety and well-being of all participants by monitoring for any adverse effects throughout the trial.

Ethical Considerations: The study will adhere to ethical standards, with approval from the Medical Research Ethics Committee of Mansoura Faculty of Medicine. Informed consent will be obtained from all participants, and their privacy and confidentiality will be maintained throughout the study.

Statistical Analysis: Data will be analyzed using SPSS software (version 26.0). Qualitative data will be presented as counts and percentages, while quantitative data will be presented as means ± standard deviations or medians and interquartile ranges depending on data distribution. Statistical significance will be set at a p-value of ≤ 0.05.

Conclusion: The results of this study will help determine whether probiotics or synbiotics can be used as an effective nutritional intervention for hemodialysis patients. By addressing gut microbiota imbalances and promoting better nutritional health, probiotics or synbiotics could potentially improve patient outcomes and quality of life.

Conditions

Hemodialysis; Probiotics; Synbiotics; Nutritional Status

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control Group (No Intervention)

This arm will include 20 participants who will not receive any treatment. The purpose of this group is to serve as a baseline for comparison with the two intervention arms. Participants will undergo regular hemodialysis treatment, but no probiotic or synbiotic supplementation will be provided.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Probiotic Group

This arm will consist of 20 participants who will receive daily probiotic supplementation (Lactogemikan from Pescado Company, containing Lactobacillus plantarum). The objective is to evaluate the effect of probiotics on the nutritional status, including BMI, skin fold thickness, and protein metabolism in hemodialysis patients. Participants will receive the probiotic for a duration of 6 months.

Group Type: EXPERIMENTAL

Lactogemikan (Probiotic Supplement)

Intervention Type: DIETARY_SUPPLEMENT

This intervention involves daily supplementation of Lactogemikan from Pescado Company, which contains Lactobacillus plantarum, a well-known probiotic strain. The probiotic is intended to improve gut microbiota balance, which may lead to improved nutritional status and health outcomes in hemodialysis patients. The dosage is one tablet daily for a duration of six months.

Synbiotic Group

This arm will include 20 participants who will receive daily synbiotic supplementation, which includes both probiotics (Lactogemikan from Pescado Company) and prebiotic fiber (oat, 3g/day). The purpose of this arm is to assess the impact of synbiotics on the nutritional status and gut microbiota balance of hemodialysis patients. Participants will receive the synbiotic for 6 months.

Group Type: EXPERIMENTAL

Lactogemikan + Prebiotic Fiber (Synbiotic Supplement)

Intervention Type: DIETARY_SUPPLEMENT

This intervention involves daily supplementation of Lactogemikan (containing Lactobacillus plantarum) combined with prebiotic fibers from oat (3g per day). The synbiotic is designed to provide the benefits of both probiotics (to balance gut microbiota) and prebiotics (to support the growth of beneficial bacteria). This intervention is intended to improve the nutritional status of hemodialysis patients over a 6-month period. The dosage is one tablet daily, combined with 3g of oat fiber.

Interventions

Lactogemikan (Probiotic Supplement)

This intervention involves daily supplementation of Lactogemikan from Pescado Company, which contains Lactobacillus plantarum, a well-known probiotic strain. The probiotic is intended to improve gut microbiota balance, which may lead to improved nutritional status and health outcomes in hemodialysis patients. The dosage is one tablet daily for a duration of six months.

Intervention Type: DIETARY_SUPPLEMENT

Lactogemikan + Prebiotic Fiber (Synbiotic Supplement)

This intervention involves daily supplementation of Lactogemikan (containing Lactobacillus plantarum) combined with prebiotic fibers from oat (3g per day). The synbiotic is designed to provide the benefits of both probiotics (to balance gut microbiota) and prebiotics (to support the growth of beneficial bacteria). This intervention is intended to improve the nutritional status of hemodialysis patients over a 6-month period. The dosage is one tablet daily, combined with 3g of oat fiber.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Patients with End-Stage Renal Disease (ESRD) on regular hemodialysis (3 times per week).
• Age 18 years or older.
• Not prepared for kidney transplantation for more than 1 year.
• Able and willing to provide written informed consent to participate in the study.

Exclusion Criteria

• Patients who are actively preparing for kidney transplantation.
• Pregnant or breastfeeding women.
• Patients with active malignancy or undergoing cancer treatment.
• Patients with known structural gastrointestinal (GI) disease (e.g., inflammatory bowel disease, severe gastrointestinal motility disorders).
• Patients who have severe infections or other severe conditions that might interfere with the study's assessments.
• Patients with known allergies to probiotics or synbiotics.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Walaa Mamdouh Mohamed Mahmoud

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Walaa M Mohamed Mahmoud, M.B.B. Ch

Role: CONTACT

walaamamdouh@mans.edu.eg

+201098344385

References

Simoes-Silva L, Araujo R, Pestana M, Soares-Silva I, Sampaio-Maia B. The microbiome in chronic kidney disease patients undergoing hemodialysis and peritoneal dialysis. Pharmacol Res. 2018 Apr;130:143-151. doi: 10.1016/j.phrs.2018.02.011. Epub 2018 Feb 11.

Reference Type: BACKGROUND

PMID: 29444477 (View on PubMed)

Nguyen TTU, Kim HW, Kim W. Effects of Probiotics, Prebiotics, and Synbiotics on Uremic Toxins, Inflammation, and Oxidative Stress in Hemodialysis Patients: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. J Clin Med. 2021 Sep 28;10(19):4456. doi: 10.3390/jcm10194456.

Reference Type: BACKGROUND

PMID: 34640474 (View on PubMed)

Liu S, Liu H, Chen L, Liang SS, Shi K, Meng W, Xue J, He Q, Jiang H. Effect of probiotics on the intestinal microbiota of hemodialysis patients: a randomized trial. Eur J Nutr. 2020 Dec;59(8):3755-3766. doi: 10.1007/s00394-020-02207-2. Epub 2020 Feb 28.

Reference Type: BACKGROUND

PMID: 32112136 (View on PubMed)

Ley RE, Turnbaugh PJ, Klein S, Gordon JI. Microbial ecology: human gut microbes associated with obesity. Nature. 2006 Dec 21;444(7122):1022-3. doi: 10.1038/4441022a.

Reference Type: BACKGROUND

PMID: 17183309 (View on PubMed)

Other Identifiers

MS.23.05.2418

Identifier Type: -

Identifier Source: org_study_id